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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K142290
Device Name KangLi pedical screw spinal system
Applicant
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Sha Zhou E. Rd.
Zhangjiagang City,  CN 215625
Applicant Contact Jin Hua Huang
Correspondent
Shanghai Yarui Consultant Co., Ltd.
503 Rm., 8 Bldg., 600 Liu Zhou Rd.
Shanghai,  CN 200233
Correspondent Contact Alice Gong
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received08/18/2014
Decision Date 11/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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